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We are looking for an experienced Automation Engineer to join our team! As an Automation Lead, he will be responsible for maintenance and automation of sterile processes equipment.

Control & Automation Lead duties and responsibilities

  • Exploring and implementing new ways to automate systems.
  • Designing and testing automation equipment and processes.
  • Programming new automated components.
  • Identifying automation related quality events and writing reports.
  • Eliminating defects and errors with hardware and software.
  • Collaborating with vendors for online breakdown management.

Key responsibilities of the Control & Automation Lead include:

Key Technical Competencies Required

  • Managing and maintaining Control systems equipment, and energy management systems
  • Optimization of automation and controls systems designs & Creation of automation standards for existing and new sites.
  • Technical support to internal customer issues, resolve automation system related issues to mitigate the associated operational risks in the areas of continuous production activities, GMP Compliance, Business and EHS.
  • Lead and support technical root cause analysis, incident investigations and troubleshooting issues related to instrumentation and equipment control systems.
  • Collaborating with cross-functional teams to identify opportunities for improvement and optimization of automation systems
  • Support the operation/ownership Data Monitoring & Control System.
  • Automation experience (Installation and configuration of human machine interfaces (HMI) and SCADA systems)
  • Support set-up of automation function for (SCADA ,IT Protocols ,configuration of servers, CMMS, BMS & EMS).
  • Work with the Project Team to execute a timely start-up to the Automation project.
  • Ensure high levels of uptime for all required systems to support Manufacturing plans
  • Ensure compliance with regulatory policies including Quality, IT Security and EHS.
  • Lead upgrade projects, as appropriate, to avoid problems caused by obsolescence.
  • Act as a Subject Matter Expert for Automation
  • Ownership and administration of process automation systems in a GMP regulated manufacturing(OSD & Injectable and Utilities areas).
  • Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures.
  • Solve complex problems, deliver lifecycle management and operational excellence.
  • Develop and manage change control requests per established SOPs and processes.
  • Critically analyzing designs of existing systems, developing and recommending continuous improvements in line with the latest technology and regulatory standards.
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
  • Excellent understanding of Automation & Control principles.
  • Excellent Technical, analytical and organizational skills
  • Independent, self-motivated, organized and able to multi-task in project environments.
  • Clear and concise technical writing, and communication/presentation skills
  • Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
  • Proficient in managing relationships with stakeholders, coordinating and collaborating with teams from different departments in order to achieve common goals.
  • Travel at various times may be required to support execution of projects
  • Proficient in the problem solving, technical support, maintenance, specification adherence and validation of Process Control system.

System Owner - Project Support

  • Provide technical hardware, software and coding expertise to ensure new and upgraded systems are provided and maintained to meet business compliance and performance requirements.
  • Manage miscellaneous 'small / medium projects', which will include; responsibility for management & co-ordination of project definition, engineering design, purchasing, installation, commissioning & qualification of equipment.
  • Support new technology introductions by performing engineering assessments, implementing automation system configuration changes, and supporting engineering and qualification runs.
  • Contribute to the development, implementation and maintenance of a Good Engineering Practice platform for effective delivery of projects.

Computerized System Life Cycle

  • Generate disaster recovery plans / procedure for site Computerized Systems (Configuration management, system backup).
  • To support Computer Systems Validation for site Computerized Systems (Commissioning, Qualification, Operation).
  • Support the review of Automation & Control maintenance plans.
  • Support the continuous improvement of the Computerized System Life Cycle.
  • Support the reduction of Automation & Control maintenance plans via data driven equipment performance and FMEA assessment.
  • Create, maintain, and execute Automation & Control maintenance procedures for equipment / computerized systems, including use of appropriate personal protective equipment & safety procedures.
  • Develop training methods / plans to be used to train members of the Engineering team and across functions: Maintenance / Operations.
  • Provide computerized system configuration and user access management configuration management appropriate to each Computerized System.

Quality System

  • Document and investigate Automation & Control adverse events in accordance with site Unplanned Event procedures.
  • Complete Quality system activities and records within respective due dates.
  • Act as subject matter expert for review and implementation of Automation & Control tasks.
  • Complete site training requirements.
  • Adhere to all site policies and procedures to maintain the culture of quality compliance with Good Manufacturing Practices and Good Documentation Practices.

EHS Compliance

  • Ensure Compliance with site EHS systems and procedures e.g. Emergency response, Incident/Accident Investigation procedures etc.
  • Ensure contractors are working within safety guidelines, using correct procedures and equipment.
  • Ensure high standards of housekeeping are maintained in the area
  • Ensure closure of EHS actions raised in a timely manner.
  • Ensure attendance at EHS training modules as defined by the site training calendar.
  • Bring to the attention of supervisor / manager / Safety Rep., EHS any suggestions that can improve safety on site.
  • Ensure appropriate Personal protective clothing is worn at all times as detailed in SOPs.
  • Ensure participation in relevant EHS unplanned events and ensure accidents/incidents are reported in a timely manner as assigned by the area Manager.

Control & Automation Assistant Lead requirements and qualifications

  • Minimum of a bachelor’s degree in Instrumentation / CS&ML engineering or similar field.
  • Proficiency in maintaining automation equipment.
  • Experience with robotics, AI and machine learning
  • Experience with project management
  • Solid understanding of computer programming and software development
  • Ability to troubleshoot equipment and perform complex system tests
  • Strong leadership and problem-solving skills
  • Excellent organizational skills and attention to detail
  • Creative thinking skills
  • Excellent verbal and written communication skills
  • Strong analytical skills
  • Ability to communicate well with other members of the team
  • Excellent manual dexterity
  • Ability to keep up with the latest technologies.
  • A desire to continually upgrade technical knowledge.
  • Experience with programming and troubleshooting PLC (e.g. Allen Bradley, Siemens), SCADA (e.g. IFix, InTouch, WinCC, Zenon, Ignition, Blue mountain, Infinity, Track wise and Veeva quality software) in pharmaceutical industry.
  • Industrial Networking experience with ControlNet (CNET), Device Net, Profibus etc.
  • Experienced in the use of Automation support tool such as RSLinx, RSNetworx, FactoryTalk Network Monitoring and architecture and SQL Data Historian.
  • Knowledge of GAMP software development lifecycle standards: GAMP5, FDA 21 CFR Part 11 and EU Annex 11.
  • Working knowledge of network architecture technologies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls
  • Solid leadership, technical writing, and communication/presentation skills
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices
  • Experience and involvement with successful Pre-Approval Inspection or equivalent regulatory audit involving Programmable Electronic Systems is desirable. 
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Confirmed 19 hours ago. Posted 30+ days ago.

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